MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P12.5-80B275
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
It was reported that during interoperative testing performed after the nail was implanted, the nail failed to lengthen.The nail was exchanged with another nail, which lengthened successfully during testing.No patient harm or impact was reported.
Additional Manufacturer Narrative
Additional data: b5, d9, h3, h6, h10.Device evaluation: upon return, visual inspection showed no visible damage on the outside of the nail.X-ray images of the internal components revealed a damaged anti-jam washer.The nail was functionally tested and was unable to distract or retract with the electronic remote controller (erc) and high-speed magnet.Force and stroke testing showed no signs of distraction, indicating the unit was jammed.The returned nail¿s device history records (dhr) were reviewed and they indicated the length of the nail was 274.31 mm at time of manufacture, compared to the length of the nail as received, which was measured at 273.89 mm.The difference between the measurement of the nail at time of manufacture and return for complaint was 0.42 mm.The shorter length measured at the time of the complaint investigation indicated that the nail had been retracted.Based off the information reported to the manufacturer and investigation findings, the nail was determined to be possibly jammed due to repeated retraction force from improper use of the external remote controller (erc)/fast distractor.The erc/fast distractor unit may have been held in the incorrect orientation during the inspection at the back table causing the device to be retracted instead of being distracted.Device records review: device history records indicates no nonconformance or deviations associated with the work order and that the unit met the required quality inspections prior to release.
Event or Problem Description
No additional information was provided.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13367662
• Report Number: 3006179046-2022-00115
• Device Sequence Number: 20159425
• Product Code: HSB
• UDI-Device Identifier: 00812258020330
• UDI-Public: 812258020330
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P12.5-80B275
• Device Lot Number: 1062103AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 109 KG